Quality by Design (QbD) approach to optimize the formulation of Multiunit Particulate System (MUPS)
The objective of this study was to develop and evaluate a MUPS formulation intended for treatment digestive tract ulcers.Work involves evaluation of different formulations of esomeprazole magnesium having enteric polymer and plasticizers to understand impact on dissolution.
A three-factor, two-level, full factorial design was used to investigate the influence of Eudragit L 100 55, Diethyl phthalate and Polyethylene glycol 6000 of the coating composition on the response, i.e., dissolution. Eudragit L 100-55 and Diethyl phthalate had a significant influence on dissolution, while Polyethylene glycol 6000 within studied level showed non- significant impact. Graphical analysis from pare to chart and half normal plots, enabled identification of variables active on the selected responses.
The optimized formulation comprised of Eudragit L-100-55: 46.42mg/tablet, Diethyl phthalate: 6.14mg/tablet and Polyethylene glycol 6000: 0.71mg/tablet showed acid resistance and a desired release of Esomeprazole magnesium. Gastro-resistant MUPS formulation has been successfully developed for Esomeprazole Magnesium. Download the full publication here: quality-by-design-qbd-approach-to-optimize-the-formulation-of-multiunit-particulate-system-mups.pdf